Statex - Pharmacology:

The precise mechanism of the analgesic action of morphine is unknown. However, specific CNS opiate receptors have been identified and likely play a role in the expression of analgesic effects. The mechanism of respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.

Statex for patients

If clinically advisable, patients receiving ORAMORPH SR brand of morphine sulfate sustained release tablets,
should be given the following instructions by the physician:

Statex may produce psychological and/or physical dependence. For this reason, the dose of the drug should not
be increased without consulting a physician.

Statex should not be taken with alcohol or other CNS de-pressants (sleep aids, tranquilizers) because
additive effects, including CNS depression, may occur. A physician should be consulted if other prescription and/or
over-the-counter medications are currently being used or are prescribed for future use.

For women of childbearing potential, who become or are planning to become pregnant, a physician should be
consulted regarding analgesics and other drug use.

Storage: ORAMORPH SR Tablets should be stored in unopened containers at or below room temperature.

Caution: Federal law prohibits dispensing without prescription. Federal law prohibits the transfer of this
drug to any person other than the patient for whom it was prescribed.

Safety and Handling Instructions: ORAMORPH SR is supplied as tablets that pose little risk of direct
exposure to health care personnel and should be handled and disposed of in accordance with hospital policy. Patients
and their families should be instructed to dispose of ORAMORPH SR tablets, that are no longer needed, down the
toilet.

Statex Interactions

Use with Other Central Nervous System Depressants: The depressant effects of morphine are
potentiated by the presence of other CNS depressants such as alcohol, sedatives, antihistaminics, or psychotropic
drugs. Use of neuroleptics in conjunction with oral morphine may increase the risk of respiratory depression,
hypotension and profound sedation or coma.

Interaction with Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e.,
pentazocine, nalbuphine, butorphanol, or buprenorphine) should NOT be administered to patients who have received or
are receiving a course of therapy with a proof opioid agonist analgesic. In these patients, the mixed
agonist/antagonist may alter the analgesic effect or may precipitate withdrawal symptoms.

Statex Contraindications

ORAMORPH SR is contraindicated in patients with respiratory depression in the absence of resuscitative equipment,
in patients with acute or severe bronchial asthma and in patients with known hypersensitivity to morphine.

ORAMORPH SR is contraindicated in any patient who has or is suspected of having a paralytic ileus.